To Evaluate the Efficacy and Safety of Minocycline Hydrochloride Foam in the Treatment of Moderate-to-severe Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

A Phase 3, Multi-center, Randomized, Double-Blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of Topical Administration of Minocycline Hydrochloride Foam (4%) in the Treatment of Moderate-to-Severe Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04960930
• Other study ID #: CU-10201-301
• Status: Completed
• Phase: Phase 3
• Start date: September 17, 2021
• Est. completion date: October 14, 2022

Study information

• Verified date: February 2023
• Source: Cutia Therapeutics (Shanghai) Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, multicenter, double-blind, vehicle-controlled, 2-arm study to evaluate the safety and efficacy in 12 weeks of FMX101 minocycline foam, 4%, compared to vehicle, in the treatment of subjects with moderate to severe facial acne vulgaris.

Description:

Qualified subjects will be randomized to receive 1 of the following 2 treatments:

• FMX101 4% minocycline foam

• Vehicle foam

Subjects with qualifying lesion counts and Investigator's Global Assessments (IGA) of acne severity scores and will be assigned to 1 of 2 treatments according to the randomization schedule. Subjects will apply the assigned study drug topically once daily for 12 weeks as directed. Subjects will be advised to apply the study drug at approximately the same time each day, preferably in the evening at bedtime. Both the Investigator and subject will be blinded to the study drug identity.

Subjects will return for visits at Weeks 1, 2, 4, 6, 8, and 12. At the discretion of the clinic staff, for the convenience of subjects or clinic staff, visits can be scheduled to occur 2 days before or after the nominal schedule date for the Weeks 1, 2, 4, 8 and 12 visits. Efficacy evaluations (acne lesion counts and IGAs) will be performed at each visit during the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 372
• Est. completion date: October 14, 2022
• Est. primary completion date: September 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years and older

Eligibility

Inclusion Criteria:

1. Has completed and signed an appropriately administered Informed Consent Form (ICF) prior to any study-related procedures. Subjects less than 18 years of age (or as required by state law) must sign an Assent Form for the study and a parent or legal guardian must sign the ICF.

2. Has facial acne vulgaris with:

• 20 to 50 inflammatory lesions (papules, pustules, and nodules)

• 25 to 100 non-inflammatory lesions (open and closed comedones)

• No more than 2 nodules on the face

• IGA score of moderate (3) to severe (4)

3. Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin Cleanser) and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study.

Exclusion Criteria:

1. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations.

2. Sunburn on the face.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• FMX101
topically once daily

Locations

Country	Name	City	State
China	Beijing Tsinghua Changgung Hospital	Beijin	Beijin
China	China-Japan Friendship Hospital	Beijin	Beijin
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Peking University Shougang Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	Xuanwu Hospital Capital Medical University	Beijing	Beijing
China	The First Bethune Hosptial of Jilin University	Changchun	Jiling
China	The Third Xiangya Hospital Of Central South University	Changsha	Hunan
China	West China Hospital Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital Of Chongqing Medical University	Chongqing	Chongqing
China	The Southwest Hospital Of Amu	Chongqing	Chongqing
China	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Hangzhou Third People's Hospital	Hangzhou	Zhejiang
China	Sir Run Run Shaw Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The Second Affiliated Hosptial Zhejiang University School Of Medicine	Hangzhou	Zhejiang
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Institute of Dermatology Chinese Academy of Medical Sciences	Nanjin	Jiangsu
China	The Affiliated Hosptial of Qingdao University	Qingdao	Shandong
China	Shanghai Medical College of Fudan University	Shanghai	Shanghai
China	Shanghai Skin Disease Hospital Skin Disease Hospital of Tongji University	Shanghai	Shanghai
China	Shengjin Hospital of China Medical University	Shenyang	Liaoning
China	The First Hosptial of China Medical University	Shenyang	Liaoning
China	The Second Hospital Of Hebei Medical University	Shijiazhuang	Hebei
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital	Tianjing	Tianjing
China	Wuxi People's Hospital	Wuxi	Jiangsu
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	Dermatology Hosptial of Southern Medical University	Yuexiu	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Cutia Therapeutics (Shanghai) Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ILC	The efficacy assessments will inflammation lesion counts at week12	Week12
Secondary	Investigator Global Assessment (IGA)	Severity of acne vulgaris assessed by Investigator Global Assessment (IGA) IGA Scale for Acne Vulgaris for study is 0-5, score 0 is clear and normal, and score 5 is very severe.	week 12
Secondary	nILC	The efficacy assessments will non-inflammation lesion counts at baseline and week12	week 12
Secondary	ILC week4	The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 4	week 4
Secondary	ILC week8	The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 8	week 8
Secondary	Investigator Global Assessment (IGA) week4	IGA Treatment Success at Week 4 IGA Scale for Acne Vulgaris for study is 0-5, score 0 is clear and normal, and score 5 is very severe.	Week 4
Secondary	Investigator Global Assessment (IGA) week8	IGA Treatment Success at Week 8 IGA Scale for Acne Vulgaris for study is 0-5, score 0 is clear and normal, and score 5 is very severe.	Week 8